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Trial record 9 of 30 for:    Guatemala | Dominican Republic

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

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ClinicalTrials.gov Identifier: NCT01003990
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition HIV
Interventions Drug: Atazanavir
Drug: Atazanavir/Ritonavir
Drug: Tenofovir/Emtricitabine
Drug: Lopinavir/ritonavir
Enrollment 710

Recruitment Details 710 participants were enrolled, 709 were treated. The participant who did not receive treatment was enrolled in error having been assigned to efavirenz in the parent study AI424034 (only subjects assigned to ATV rolled over into AI424077).
Pre-assignment Details  
Arm/Group Title Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Hide Arm/Group Description Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)

Period Title: Overall Study
Started 459 154 96
Completed 367 103 53
Not Completed 92 51 43
Reason Not Completed
Adverse Event             8             5             11
Death             0             8             1
Lack of Efficacy             10             2             3
Lost to Follow-up             30             12             7
Reasons Not Identified             14             13             8
Poor/Non-compliance             4             3             2
Pregnancy             10             2             4
No Longer Met Study Criteria             4             1             0
Subject Withdrew Consent             12             5             7
Arm/Group Title Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV) Total
Hide Arm/Group Description Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)

Total of all reporting groups
Overall Number of Baseline Participants 459 154 96 709
Hide Baseline Analysis Population Description
All Treated Participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 459 participants 154 participants 96 participants 709 participants
36.6  (9.00) 35.9  (8.81) 37.6  (10.16) 36.6  (9.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 459 participants 154 participants 96 participants 709 participants
Female
172
  37.5%
54
  35.1%
30
  31.3%
256
  36.1%
Male
287
  62.5%
100
  64.9%
66
  68.8%
453
  63.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 459 participants 154 participants 96 participants 709 participants
White
158
  34.4%
34
  22.1%
18
  18.8%
210
  29.6%
Black or African American
112
  24.4%
25
  16.2%
2
   2.1%
139
  19.6%
American Indian/Alaska Native
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
53
  11.5%
13
   8.4%
18
  18.8%
84
  11.8%
Other
135
  29.4%
82
  53.2%
58
  60.4%
275
  38.8%
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
Time Frame Date of First Dose to 30 days post the last dose; approximately 405 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Hide Arm/Group Description:
Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)

Overall Number of Participants Analyzed 459 154 96
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
35
   7.6%
19
  12.3%
12
  12.5%
Treatment Related SAEs
4
   0.9%
1
   0.6%
0
   0.0%
Treatment Related AEs of Any Grade
180
  39.2%
49
  31.8%
34
  35.4%
AEs Leading to Discontinuation of Study Therapy
8
   1.7%
5
   3.2%
11
  11.5%
Grade 3 to Grade 4 AEs
72
  15.7%
27
  17.5%
15
  15.6%
Grade 2 to Grade 4 AEs
102
  22.2%
28
  18.2%
19
  19.8%
CDC Class C AIDS Events
2
   0.4%
0
   0.0%
0
   0.0%
Deaths
2
   0.4%
7
   4.5%
1
   1.0%
Time Frame Date of first dose to date of last dose plus 30 days; approx. 680 weeks
Adverse Event Reporting Description

All Treated Participants

Study Initiated: November 13, 2002 Study Completion: February 16, 2016

 
Arm/Group Title Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Hide Arm/Group Description Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)

All-Cause Mortality
Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/459 (0.44%)   7/154 (4.55%)   1/96 (1.04%) 
Show Serious Adverse Events Hide Serious Adverse Events
Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/459 (7.63%)   19/154 (12.34%)   12/96 (12.50%) 
Blood and lymphatic system disorders       
Leukaemoid reaction  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Bicytopenia  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Pancytopenia  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Cardiac disorders       
Acute coronary syndrome  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  2/459 (0.44%)  0/154 (0.00%)  0/96 (0.00%) 
Gastrointestinal disorders       
Vomiting  1  1/459 (0.22%)  1/154 (0.65%)  0/96 (0.00%) 
Proctitis ulcerative  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Pancreatitis  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Anal fistula  1  1/459 (0.22%)  1/154 (0.65%)  0/96 (0.00%) 
Acute abdomen  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Gastric ulcer perforation  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Melaena  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Haemorrhoidal haemorrhage  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Haemorrhoids  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Ileus  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
General disorders       
Oedema  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Pyrexia  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Hepatobiliary disorders       
Gallbladder polyp  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Drug-induced liver injury  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Cholelithiasis  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Infections and infestations       
Pneumonia  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Cervicitis  1  0/459 (0.00%)  1/154 (0.65%)  1/96 (1.04%) 
Herpes zoster  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Neurosyphilis  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Abdominal infection  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Pyelonephritis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Tooth abscess  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Anal abscess  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Appendiceal abscess  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Hepatitis A  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Influenza  1  2/459 (0.44%)  0/154 (0.00%)  0/96 (0.00%) 
Peritonitis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Pulmonary tuberculosis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Tuberculosis  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Septic shock  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Upper respiratory tract infection  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Bacteraemia  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Cellulitis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Infective tenosynovitis  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Appendicitis  1  1/459 (0.22%)  1/154 (0.65%)  1/96 (1.04%) 
Extrapulmonary tuberculosis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Mastoiditis  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Injury, poisoning and procedural complications       
Accidental exposure to product  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Limb traumatic amputation  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Spinal fracture  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Open fracture  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Traumatic ulcer  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Humerus fracture  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Thermal burn  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Limb injury  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Contusion  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Musculoskeletal and connective tissue disorders       
Tenosynovitis  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Osteonecrosis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Lipoma  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Uterine leiomyoma  1  1/459 (0.22%)  2/154 (1.30%)  1/96 (1.04%) 
Colon neoplasm  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Invasive ductal breast carcinoma  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Colon cancer  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Hodgkin's disease nodular sclerosis  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Testicular neoplasm  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Cervix carcinoma stage 0  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Nervous system disorders       
Somnolence  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Headache  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Syncope  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Dizziness  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion incomplete  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Abortion  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Ectopic pregnancy  1  2/459 (0.44%)  0/154 (0.00%)  0/96 (0.00%) 
Psychiatric disorders       
Depression  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Major depression  1  2/459 (0.44%)  0/154 (0.00%)  0/96 (0.00%) 
Suicide attempt  1  1/459 (0.22%)  0/154 (0.00%)  1/96 (1.04%) 
Acute psychosis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Bipolar disorder  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Renal and urinary disorders       
Renal failure  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Nephrolithiasis  1  1/459 (0.22%)  1/154 (0.65%)  0/96 (0.00%) 
Reproductive system and breast disorders       
Dysfunctional uterine bleeding  1  0/459 (0.00%)  2/154 (1.30%)  0/96 (0.00%) 
Uterine disorder  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Cervical dysplasia  1  0/459 (0.00%)  1/154 (0.65%)  1/96 (1.04%) 
Endometrial hypertrophy  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Asthma  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
Asphyxia  1  0/459 (0.00%)  1/154 (0.65%)  0/96 (0.00%) 
Nasal septum deviation  1  0/459 (0.00%)  0/154 (0.00%)  1/96 (1.04%) 
Vascular disorders       
Deep vein thrombosis  1  1/459 (0.22%)  0/154 (0.00%)  0/96 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atazanavir (ATV) Atazanavir/Ritonavir (ATV/RTV) Lopinavir/Ritonavir (LPV/RTV)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   284/459 (61.87%)   92/154 (59.74%)   57/96 (59.38%) 
Eye disorders       
Ocular icterus  1  31/459 (6.75%)  4/154 (2.60%)  0/96 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  47/459 (10.24%)  22/154 (14.29%)  12/96 (12.50%) 
Abdominal pain upper  1  13/459 (2.83%)  2/154 (1.30%)  6/96 (6.25%) 
Abdominal pain  1  20/459 (4.36%)  8/154 (5.19%)  4/96 (4.17%) 
Gastritis  1  12/459 (2.61%)  8/154 (5.19%)  3/96 (3.13%) 
Nausea  1  19/459 (4.14%)  4/154 (2.60%)  5/96 (5.21%) 
General disorders       
Pyrexia  1  12/459 (2.61%)  9/154 (5.84%)  3/96 (3.13%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  45/459 (9.80%)  3/154 (1.95%)  1/96 (1.04%) 
Jaundice  1  24/459 (5.23%)  5/154 (3.25%)  1/96 (1.04%) 
Infections and infestations       
Nasopharyngitis  1  51/459 (11.11%)  32/154 (20.78%)  24/96 (25.00%) 
Urinary tract infection  1  11/459 (2.40%)  11/154 (7.14%)  2/96 (2.08%) 
Influenza  1  32/459 (6.97%)  16/154 (10.39%)  6/96 (6.25%) 
Upper respiratory tract infection  1  74/459 (16.12%)  10/154 (6.49%)  4/96 (4.17%) 
Bronchitis  1  32/459 (6.97%)  8/154 (5.19%)  6/96 (6.25%) 
Investigations       
Alanine aminotransferase increased  1  27/459 (5.88%)  5/154 (3.25%)  3/96 (3.13%) 
Creatinine renal clearance decreased  1  0/459 (0.00%)  16/154 (10.39%)  8/96 (8.33%) 
Blood bilirubin increased  1  34/459 (7.41%)  3/154 (1.95%)  1/96 (1.04%) 
Blood cholesterol increased  1  0/459 (0.00%)  4/154 (2.60%)  7/96 (7.29%) 
Metabolism and nutrition disorders       
Hypertriglyceridaemia  1  6/459 (1.31%)  7/154 (4.55%)  12/96 (12.50%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  27/459 (5.88%)  13/154 (8.44%)  12/96 (12.50%) 
Arthralgia  1  21/459 (4.58%)  12/154 (7.79%)  5/96 (5.21%) 
Nervous system disorders       
Headache  1  37/459 (8.06%)  15/154 (9.74%)  8/96 (8.33%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  12/459 (2.61%)  7/154 (4.55%)  6/96 (6.25%) 
Asthma  1  4/459 (0.87%)  1/154 (0.65%)  6/96 (6.25%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01003990     History of Changes
Other Study ID Numbers: AI424-077
First Submitted: October 20, 2009
First Posted: October 29, 2009
Results First Submitted: February 2, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017